This FOA encourages a wide range of collaborative research
projects related to patient safety in the context of both routine as well as
intensive newborn care. The FOA welcomes applications related to (but not
limited to): the epidemiology of various domains of medical errors and
consequent patient harm; assessing the factors at various levels that
contribute to such errors; and intervention strategies at individual,
systems, and institutional-levels to help reduce and eliminate medical errors
in the context neonatal care. It is anticipated that knowledge gained from
these projects will help develop strategies to deliver highest quality of
healthcare to all newborn infants with utmost safety and effectiveness.

Key Dates

Posted Date

June 9, 2011

Open Date (Earliest Submission Date)

August 19, 2011

Letter of Intent Due Date

August 19, 2011, August 19, 2012, August 19, 2013

Application Due Date(s)

September 19, 2011, September 19, 2012, September 19, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012, February/March 2013, February/March
2014

Advisory Council Review

May 2012, May 2013, May 2014

Earliest Start Date(s)

July 2012, July 2013, July 2014

Expiration Date

September 20, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF 424
(R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

This FOA encourages a wide range of collaborative research
projects related to patient safety in the context of both routine as well as
intensive newborn care. The FOA welcomes applications related to (but not
limited to): the epidemiology of various domains of medical errors and
consequent patient harm; assessing the factors at various levels that
contribute to such errors; and intervention strategies at individual, systems,
and institutional-levels to help reduce and eliminate medical errors in the context
neonatal care. It is anticipated that knowledge gained from these projects will
help develop strategies to deliver highest quality of healthcare to all newborn
infants with utmost safety and effectiveness.

Background

Over past decade, there has emerged an increased awareness
about the need to offer quality care to all patients with utmost safety
effectiveness. Yet, case reports and observational studies continue to report
adverse events from medical errors during pediatric healthcare, including routine
as well as neonatal intensive care. For a number of reasons described below,
newborn infants may be particularly at higher risk for sustaining injury from
medical errors than older patients. It is also known that healthcare-related
errors seldom occur in isolation, and a complex series of factors may operate
leading to errors and consequent patient injury. Thus, there is a need for more
collaborative research to understand the epidemiology (frequency, causes, types
of errors, factors causing them, etc.) and to develop effective prevention
strategies that is can be implemented across healthcare facilities in the
United States.

The need for improving patient safety was highlighted in the
Institute of Medicine Report, "To Err is Human: Building a Safer Health
System" published in 2000. Since then patient safety issues have received
more attention from the scientific community, regulatory agencies, and the
general public. However, an expert panel convened by the Eunice Kennedy Shriver
National Institute of Child Health and Human Development concluded that more
research is needed to address and improve patient safety issues related to
neonatal care . This FOA is intended, in part, to fill in knowledge gaps in
this important area of pediatric healthcare.

Since a many phrases used in the patient safety literature
have acquired specific meanings, a few are described below to avoid ambiguity.
"Patient safety" is defined as freedom from accidental injury to
anyone who is seeking healthcare. By establishing operational systems and
processes, one attempts to minimize the likelihood of errors and maximize the
likelihood of preventing them. "Medical errors" are those due to a
failure of the planned action to be completed as intended, or using a wrong
plan of action to achieve the goal. "Medication errors" are
preventable events that cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the health care
professionals, patients, or consumers. "Adverse events "are injuries
and harm resulting from a medical interventions, or lack thereof. "Near
misses" are those errors that do not result in patient harm due to chance
or timely interventions. A "diagnostic error" is a missed, wrong, or
delayed diagnosis, detected by later definitive tests, clinical findings,
histopathology, or autopsy results.

It has also been noted that errors rarely occur from the
mistakes of a single individual. Therefore, safety experts recommend a
"systems approach" to understand all of the pre-existing factors
leading to errors, which would enable developing preventing strategies.

Unique Patient Safety Issues in Neonatal Care

Because of their small size and fragility, and their
immaturity of organ systems, newborn infants are uniquely vulnerable for injury
from even minor deviations in safe care practices. Sick newborn infants in the
neonatal intensive care units (NICU) are likely to be monitored using a large
array of instruments. They are also likely to receive complex levels of care,
which can include receiving several medications, undergoing invasive procedures
for monitoring, diagnosis and treatment over extended periods of
hospitalization. There is also a possibility for receiving care from a team of
experts. All of the above factors tend to increase the potential for errors
and patient harm. There is also a narrow margin of safety; the patients are
also more likely to suffer from harmful consequences of errors sooner. Because
of their unique vulnerability, even minor errors can lead to devastating short
and long-term consequences. In large general hospitals, patient safety efforts
are likely to be targeted toward adult patients or treatment units, with little
appreciation for the unique needs of the NICUs and their patients.

Other identified reasons for increased risk for medical
errors in the context of neonatal care include, unfavorable working conditions,
healthcare provider fatigue and a large array of treatment and investigative
modalities needed for the care of high-risk newborn infants can enhance the
risk for errors (e.g., ventilator, central catheter, medications, bed-side
tests). Delay due to processing of specific identification for the newborn
infant soon after birth will lead to a necessary paring with the identification
of the mother, increasing a chance for misidentification. Additionally, there
is paucity of well-tested, safe and effective devices and instruments for use
specifically in the NICU. These issues may require specific research
strategies.

Several domains of errors and patient harm have been
identified in the context of neonatal care. These include: medication
errors; errors in administration of intravenous parenteral nutrition; delivery room
resuscitation-related, ventilator care-related errors; error and harm from
invasive procedures, health care–associated infections; patient identification
errors; and diagnostic errors. Other unique types of errors in the NICU
include: feeding of the human milk to an infant from a wrong mother,
inadvertent administration of human milk intravenously; mix-up in mother-infant
identification leading to feeding of infants with the milk of a wrong mother;
or discharging an infant to the wrong family.

Scope

Thus, research in the field of patient safety during
neonatal care is challenging with many dimensions that may require the
expertise from different fields. Through this FOA, NIH encourages applications
that address a variety of issues in the context of neonatal care. The field and
scope of the research proposals sought include, but not limited to:

Epidemiology
of errors and adverse events in the setting of neonatal intensive care

Develop prospective and retrospective study designs to collect
data on patient safety and adverse events (in collaboration with existing, or
new PSOs with well-defined outcome measures and triggers) Attempt to include
such data from multiple levels, including community hospitals, pediatric and
obstetric practices;

Study the strengths and limitations of current methods of error
reporting systems.

Study the best practices and surveillance methods, and determine
what adverse events need to be monitored, and how often

Research on medication compatibility used with total parenteral
nutrition

Assess optimal space, personnel, and other logistics at the
pharmacy preparing medications for use in the neonatal intensive care

Study the effects of simple alterations in practice on patient
safety such as: Color-coded line tubing, or line connectors to distinguish TPN
solutions from human breast milk; and large symbols with specific colors to
identify specific equipment and their storage sites.

Diagnostic
errors

Develop a uniform definition; the value of definitive procedures
(e.g., imaging studies; autopsies), and determine the epidemiology of
diagnostic errors

Assess the effects timeliness and precision (completeness) of
diagnoses on outcomes, and assess factors contributing such errors

Errors from patient misidentification

Study the value of improved bar-coding system in proper patient
identification

Develop better IDs (non-invasive or minimally invasive systems)

Develop biomarkers as unique patient identifiers

Procedure-related
errors

Test the value of simulations in training for performing invasive
procedures

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registratins must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information
contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For
this particular announcement, note the following:

The R21 exploratory/developmental grant supports
investigation of novel scientific ideas or new model systems, tools, or
technologies that have the potential for significant impact on biomedical or
biobehavioral research. An R21 grant application need not have extensive
background material or preliminary information. Accordingly, reviewers will
focus their evaluation on the conceptual framework, the level of innovation,
and the potential to significantly advance our knowledge or understanding.
Appropriate justification for the proposed work can be provided through literature
citations, data from other sources, or, when available, from
investigator-generated data. Preliminary data are not required for R21
applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of
review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants Policy
Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov
on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.